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Comparative Effectiveness of Western Pharmacotherapy Versus Integrative Western and Traditional Chinese Medicine for Weight Management in Central Taiwan: A Real-World Cohort Study

10. juni 2026 oppdatert av: National Yang Ming Chiao Tung University

Obesity is a major public health issue. While modern Western pharmacotherapies (e.g., GLP-1 receptor agonists) and Traditional Chinese Medicine (TCM) are utilized for weight management, the comparative effectiveness of their integration remains unclear. This study aims to compare the effects of Western medicine (WM) alone versus integrative WM and TCM on body weight and composition. A retrospective cohort study design will be employed, aiming to enroll approximately 500 patients (BMI ≥ 27) receiving treatment at a regional hospital in Central Taiwan. Participants will be categorized into the WM-only or WM+TCM groups. The primary outcome is the percentage of total body weight loss (%TBWL) at 6 and 12 months. Secondary outcomes include changes in body composition, including fat percentage and the muscle-to-fat ratio (MFR). Statistical analysis will utilize Propensity Score Matching (PSM) or Inverse Probability of Treatment Weighting (IPTW) to balance baseline differences and Mixed-Effects Models for Repeated Measures (MMRM) for longitudinal data analysis. Interaction effects between different WM modalities and TCM will be explored (sub-analysis). Preliminary analysis indicated that individualized treatment significantly reduced body fat and increased MFR. This study anticipates further clarifying the advantages of integrative WM+TCM and identifying the optimal synergistic combinations, providing crucial real-world evidence for clinical weight management strategies.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Fedme og overvekt

Studietype

Observasjonsmessig

Registrering (Faktiske)

296

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Taiwan
- - Taipei, Taiwan, 112
    - National Yang Ming Chiao Tung University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients with overweight or obesity receiving weight management treatment in a hospital-based outpatient setting in Taiwan. Participants were identified from a retrospective clinical database and received pharmacologic therapy, primarily semaglutide, with or without adjunctive medications and/or traditional Chinese medicine interventions.

Beskrivelse

Inclusion Criteria:

Adults aged ≥20 years
Obesity defined by Health Promotion Administration, Taiwan: BMI ≥27 kg/m², or BMI ≥24 kg/m² with metabolic comorbidities
Received weight management treatment
Primary pharmacologic therapy with: Rybelsus® (oral semaglutide), or Ozempic® (subcutaneous semaglutide)
May have received adjunctive weight-loss medications, including: Mounjaro® (tirzepatide), SGLT2 inhibitors, Contrave® (naltrexone/bupropion)

Exclusion Criteria:

Incomplete data, including missing baseline measurements or absence of follow-up records, precluding assessment of treatment effectiveness
Pregnancy or breastfeeding
History of bariatric surgery during the study period (e.g., gastric bypass, gastric banding)
Presence of major medical conditions that may significantly affect body weight independent of obesity treatment (e.g., active malignancy, end-stage organ failure)
Patients deemed unsuitable for inclusion by the investigators (e.g., poor treatment adherence or unreliable data)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Percentage change in body weight associated with Chinese herbal medicine use Tidsramme: From baseline to end of follow-up (up to 14 months)	Percentage change in body weight from baseline will be calculated and compared between participants exposed to Chinese herbal medicine and non-exposed participants during the study period.	From baseline to end of follow-up (up to 14 months)

Samarbeidspartnere og etterforskere

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Sponsor

National Yang Ming Chiao Tung University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2026

Primær fullføring (Faktiske)

28. april 2026

Studiet fullført (Antatt)

30. juni 2026

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)